Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

NCT ID: NCT04200976

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-15
• Study Completion Date: 2021-08-15

Brief Summary

Traumatic brain injury (TBI) is highly prevalent and frequently comorbid among Veterans and Service Members. Many of these individuals sustain more than one TBI over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction.

The short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of Tele-CABA for improving cognitive and adaptive functioning. The long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of Veterans and Service Members. The overall goal of the Tele-CABA intervention is to reduce negative cognitive and psychiatric health outcomes for Veterans and Service Members with a history of TBI, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from TBI.

Conditions

Traumatic Brain Injury; Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tele-CABA

Participants who engage in the Tele-CABA intervention.

Group Type: EXPERIMENTAL

Tele-CABA

Intervention Type: BEHAVIORAL

Tele-CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of Tele-CABA focus on learning about TBI and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.

The Tele-CABA intervention will be delivered over 10 weekly, 60-minute telephone sessions.

Usual Care

Participants who do not engage in the Tele-CABA intervention during their time in the study. They will be eligible to receive Tele-CABA following completion of the 6-month questionnaires and cognitive assessment (as a courtesy).

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Participants in the UC group will continue to receive their regular medical, psychiatric, and psychotherapeutic care.

Interventions

Tele-CABA

Tele-CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of Tele-CABA focus on learning about TBI and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.

The Tele-CABA intervention will be delivered over 10 weekly, 60-minute telephone sessions.

Intervention Type: BEHAVIORAL

Usual Care

Participants in the UC group will continue to receive their regular medical, psychiatric, and psychotherapeutic care.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Veterans
• Active Duty Service Members
• History of TBI (confirmed by TBI interview)
• Self-reported cognitive complaints (as indicated on the NSI)
• Able to communicate by telephone

Exclusion Criteria

• Active suicidal intent
• History of bipolar disorder
• History of psychotic disorder
• Decisionally impaired
• Non-English speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Portland VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Megan Callahan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA Portland Health Care System

Portland, Oregon, United States

Countries

United States

Other Identifiers

PortlandVAMC

Identifier Type: -

Identifier Source: org_study_id